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IN THE NEWS!

 Global Infusion Pumps Market to Reach US$5.5 Billion by 2017, According to a New Report by Global Industry Analysts, Inc.

During the NANS meeting, a physician approached me to discuss the Polyanalgesic Consensus guidelines for intrathecal therapy treatments. His question was, "Who do they serve?" He was concerned about his own treatment regiments, as he seemed to be outside the guidelines in some cases. I stated to him that the guidelines were being re-assessed, and there would be more to come for the 2011/2012 publication. I have been involved in some of the working documents of the new publication, and my advice was sought after regarding compounding pharmacy issues, as well as dosing.  

A lot has changed over the years. In the past, clinicians were dosing at higher concentrations and higher daily doses, and these guidelines have been established, in part, to steer people toward more conservative measures to reduce adverse events and optimize patient care. Additionally, they are established to assist and aid individuals who are initially getting into intraspinal infusions. However, there are still situations where more experienced clinicians will treat patients outside those guidelines. The doctor expressed some concern, essentially asking, "Am I exposed?" or "Is there a problem with my treatment of my patients?" And I think all doctors, in all parameters, experience this.

The guidelines, in my opinion, are designed for those with less familiarity; but you have clinicians who have been in the practice for 25-30 years and understand the intrathecal space and the drugs involved for intraspinal infusion. The issue with the guidelines is that they are thinking on behalf of all practitioners. Experienced practitioners have a proven track record, and there are exceptions to the guidelines that they fall outside of.

The doctor posed the question, "How hard and true are these?" I expressed to him that I don't think they are hard and true, but rather to simply guide people. One shoe doesn't fit all - nor does one guideline fit all practices. You have to be aware of the guidelines while simultaneously understanding your treatment programs.

The conversation continued with, "How do doctors decide on dosing?" It's a consensus panel, and these individuals put forth their opinion based on what they are doing to treat patients, but they also understand that what they are stating is there to provide guidance.  

During the conversation, we discussed trial dosing. We talked about the polyanalgesic panel meeting that I attended and how, for trial dosing, some panel members recommended a 24-hour hospitalization. However, other panel members said, "I do not always do this." These members expressed that they are comfortable monitoring for a shorter period of time, then sending the patient home - and they have many years of experience with this. So, do they fall outside the guidelines?

These guidelines are conservative, but people with greater experience, those with some latitude in their practice, feel comfortable operating outside the guidelines. Is there a legal component to this? I do not know. This is a difficult conversation. I am trying to convey that these guidelines are good for everyone - both clinicians and patients - but what your practice is, what your experience has been, and what is best for the patient all must be taken into consideration.

I would like to end by referring to the movie Pirates of the Caribbean: The Black Pearl. In the movie, there is a scene where Keira Knightley's character was abducted by pirates, and in order to be brought in front of the ship's captain, Captain Barbosa, she used the pirate's code-word "parlay." After negotiating with the captain - who ultimately breaks his bargain with the young woman - she expresses that he is a pirate and must follow the pirate's code. His response was, "The code is more what you'd call 'guidelines' than actual rules."

IN THE NEWS!

 2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management

THE HORSESHOE CRAB:

How nature and science are intertwined to prevent pain and save lives. 

Not too long ago, my wife and I took a vacation to Kiawah Island in South Carolina to celebrate her birthday. Early one morning we took a walk along the beach, and after a few hundred yards I came across numerous horseshoe crab exoskeletons lying in the sand. I immediately recognized the arthropod for its importance in pharmaceutical quality assurance; more specifically for the detection of endotoxins.

Bacterial endotoxins, often called pyrogens, are poisonous substances produced within living cells or organisms. These fever-producing materials most often originate from gram-negative bacterial cell walls, but can also originate as leachates from some chemicals and materials. In pharmaceutical production, especially sterile compounding, it is necessary to reduce traces of endotoxins in drug products as even small amounts will cause illness in humans.

According to USP 797 guidelines, "All high-risk level compounded sterile products (CSPs) ... before they are sterilized shall be tested to ensure that they do not contain excessive bacterial endotoxins."

Here at Hartley Medical, we allocate a substantial annual budget solely to quality assurance testing. We perform both sterility and endotoxin testing per USP requirements.

A very sensitive procedure for detecting the presence of endotoxins in drugs is the Limulus Amebocyte Lysate (LAL) test. The LAL assay utilizes the amoebocytes (blood cells) of a horseshoe crab. The lysate found in the blood binds with the dangerous endotoxins present creating a clot via a cascade of reactions; thus, forming the basis of their detection and quantification.

When it comes to LAL testing for bacterial endotoxins, there are three techniques: 1) the gel-clot technique, which is based on gel formation; 2) the turbidimetric technique, based on the development of turbidity after cleavage (the division or splitting of form) of an endogenous substrate; and 3) chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromogen complex.[1] 

Hartley Medical began endotoxin testing in 1999 utilizing the gel-clot test. In 2003, we advanced our technology to test using the turbidimetric technique; a method we still use today. This is a photometric test to measure the increase in turbidity (the cloudiness or haziness of a fluid caused by individual particles that are generally invisible to the naked eye). More specifically, we utilize kinetic-turbidimetric testing, which measures both the time (onset time) needed for the reaction mixture to reach a predetermined absorbance, and the rate of turbidity development. In the presence of endotoxins, the lysate begins to gel - causing the solution to become turbid. Higher concentrations of endotoxins cause the increase in solution turbidity to occur faster than lower concentrations. A standard curve is always run with each test. The concentration of the unknown is extrapolated from the standard curve. The time required for the appearance of turbidity is inversely proportional to the amount of endotoxins present.[2] 

It is fascinating to think of how intertwined nature and science are. Bacteria are everywhere. And, for the most part, bacteria are beneficial as they reduce organic waste and recycle nutrients back into the food chain. Sometimes, however, bacteria cause disease if they enter parts of our body that are usually bacteria-free, such as the bloodstream or the intra-spinal space- causing severe illness (such as sepsis) and/or death. Therefore, pharmaceutical companies, especially sterile compounding pharmacies, must take great care in producing drugs that are free of bacteria and non-pyrogenic. Hartley Medical recognizes the horseshoe crab's contribution to the world of pain management; and we are happy to change and save lives.

Take advantage of William's vast experience in intrathecal drug therapies! 

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